C1.99 PLUS and ELITE Service Manual P02913-02 Jan 2003

P02913-02 01/2003 Copyright 2003 by SonoSite, Inc. All rights reserved. Printed in the USA.

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Manufactured by SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021-3904 USA T: 1-888-482-9449 or 1-425-951-1200 F: 1-425-951-1201 SonoSite Ltd Alexander House 40A Wilbury Way Hitchin Herts SG4 OAP UK T: +44-1462-444800 F: +44-1462-444801

CAUTION: ` United States federal law restricts this device to sale by or on the order of a physician. “SiteCharge,” “SitePack,” “SiteStand,” and “SonoHeart,” are trademarks of SonoSite, Inc. Non-SonoSite product names may be trademarks or registered trademarks of their respective owners. SonoSite products may be covered by one or more of the following U.S. patents: 4454884, 4462408, 4469106, 4474184, 4475376, 4515017, 4534357, 4542653, 4543960, 4552607, 4561807, 4566035, 4567895, 4581636, 4591355, 4603702, (4607642), 4644795, 4670339, 4773140, 4817618, 4883059, 4887306, 5016641, 5050610, 5095910, 5099847, 5123415, 5158088, 5197477, 5207225, 5215094, 5226420, 5226422, 5233994, 5255682, (5275167), 5287753, 5305756, 5353354, 5365929, 5381795, 5386830, 5390674, 5402793, (5,423,220), 5438994, 5450851, 5456257, 5471989, 5471990, 5474073, 5476097, 5479930, 5482045, 5482047, 5485842, 5492134, 5517994, 5529070, 5546946, 5555887, 5603323, 5606972, 5617863, (5634465), 5634466, 5636631, 5645066, 5648942, 5669385, (5706819), 5715823, 5718229, 5720291, 5722412, 5752517, 5762067, 5782769, 5800356, 5817024, 5833613, 5846200, 5860924, 5893363, 5916168, 5951478, 6036643, 6102863, 6104126, 6113547, 6117085, 6142946, 6203498 B1, D0280762, D0285484, D0286325, D0300241, D0306343, D0328095, D0369307, D0379231. Other patents pending.

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Table of Contents CHAPTER

CHAPTER

1

2

Introduction

1

1.1

About the System ...1

1.2

Audience ...2

1.3

Conventions Used in This Manual...2

1.4

About the System Software ...3

1.5

Software Licensing ...3

Safety

5

2.1 Electrical Safety ...5 2.1.1 Equipment Protection ...7

CHAPTER

3

2.2

Battery Safety...8

2.3

Biological Safety...9

2.4

Labeling Symbols ...9

System Overview

11

3.1 Theory of Operation...11 3.1.1 Transducer ...12 3.1.2 Acquisition Subsystem ...12 3.1.3 Processing Subsystem ...12 3.1.4 Display Subsystem ...12 3.1.5 Control Subsystem ...12 3.1.6 User Interface Subsystem ...13 3.1.7 Power Subsystem ...13 3.2

Components ...13

3.3

Controls...14

3.4 Accessories ...15 3.4.1 Battery Pack ...15 3.4.1.1 Battery Charge Indicators ...15 3.4.2 External Power ...15 3.4.2.1 External System Connections ...16 3.4.3 Power Adapter...16 3.5 System Specifications ...17 3.5.1 Physical Dimensions ...17 3.5.2 Monitor ...17 3.5.3 Transducers ...17 3.5.4 Imaging Modes...18

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3.5.5 Image Storage...18 3.5.6 Temperature, Pressure, and Humidity Limits ...18 3.5.6.1 System Operating ...18 3.5.6.2 System Shipping/Storage ...18 3.5.6.3 Battery Operating ...18 3.5.6.4 Battery Shipping/Storage ...18 3.5.6.5 Transducers Operating ...18 3.5.6.6 Transducers Shipping/Storage ...18 3.5.7 Electrical...19 3.6

Battery...19

3.7 Safety Requirements ...19 3.7.1 Electromechanical Safety Standards ...19 3.7.2 EMC/EMI Standards ...20 3.7.3 Airborne Equipment Standards (without ECG Cable Attached) ...20 3.7.4 ECG Standard...20

CHAPTER

4

Setup and Operation

21

4.1

Connecting and Removing Transducers ...21

4.2

Turning the System On and Off...22

4.3

Installing and Removing the Battery ...23

4.4

Using AC Power ...24

4.5

Upgrading the System Software ...25

4.6 Obtaining A License Key ...27 4.6.1 Installing A License Key...27 4.6.1.1 Displaying the System Information Screen ...29 4.7

CHAPTER

CHAPTER

vi

5

6

Checking and Charging the Battery...30

Cleaning and Disinfecting

33

5.1

Universal Precautions ...33

5.2

Receipt of Suspected Contaminated Materials ...33

5.3

Recommended Disinfectants ...34

Troubleshooting

35

6.1

System and Subsystem Diagnosis...35

6.2

System Repair ...35

6.3

Test Equipment ...35

C1.99 PLUS and ELITE Ultrasound System Service Manual

6.4 Failures...36 6.4.1 Display...36 6.4.2 Control Panel...36 6.4.3 Trackball...36 6.4.4 Main PCBA ...36 6.4.5 Clearing the Main PCBA Failure ...37 6.4.6 Battery ...37

CHAPTER

7

Replacement Procedures

45

7.1 Display Subassembly Replacement ...45 7.1.1 Required Parts ...45 7.1.2 Required Tools and Materials ...45 7.1.3 Removing the Display Subassembly ...46 7.1.4 Replacing the Display Subassembly ...48 7.2 Control Panel Subassembly Replacement ...50 7.2.1 Required Parts ...50 7.2.2 Required Tools ...50 7.2.3 Removing the Control Panel Subassembly ...51 7.2.4 Replacing the Control Panel Subassembly...53 7.3 Trackball ...54 7.3.1 Required Parts ...54 7.3.2 Required Tools ...54 7.3.3 Removing the Trackball ...54 7.3.4 Replacing the Trackball...57 7.4 Main PCBA Subassembly Replacement...60 7.4.1 Required Parts ...60 7.4.2 Required Tools ...60 7.4.3 Removing the Main PCBA Subassembly ...60 7.4.4 Replacing the Main PCBA Subassembly ...62 7.5 CW Daughter/Terminator Board Replacement ...64 7.5.1 Required Parts ...64 7.5.2 Required Tools ...64 7.5.3 Removing the Termination/CW Daughter Board ...65 7.5.4 Replacing the Termination/CW Daughter Board ...65 7.6

Transducers ...65

7.7

AC Power Adapter...65

7.8 OEM Peripherals...66 7.8.1 External Monitor (Sony) ...66 7.8.2 VCR (Sony)...66 7.8.3 Printer (Sony) ...66

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CHAPTER

8

Performance Tests

67

8.1

Overview...67

8.2

Test Equipment: ...67

8.3 Setting Up Performance Tests ...68 8.3.1 Scan Reference Orientation...68 8.4 Testing 2D Performance ...68 8.4.1 2D Image Quality ...68 8.4.2 Axial Measurement Accuracy ...69 8.4.3 Lateral Measurement Accuracy ...69 8.4.4 Penetration...70 8.5 Additional Performance Tests ...70 8.5.1 CPD ...70 8.5.2 Directional Color Power Doppler (DCPD) ...71 8.5.3 M-mode Imaging...71 8.5.4 Tissue Harmonic Imaging ...72 8.5.5 Pulsed Wave (PW) Doppler Imaging...72 8.5.6 ECG Monitoring...72 8.5.7 Continuous Wave (CW) Doppler Imaging...73 8.5.8 Image Quality Verification Test...73 8.5.9 Image Review...73 8.5.10 Printer ...73 8.5.11 Battery Charging ...73 8.5.12 Video Output ...75 8.6 Returning Products to SonoSite ...75 8.6.1 Contacting SonoSite Technical Support ...75 8.6.2 Shipping Instructions...75

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APPENDIX

A

Parts List

77

APPENDIX

B

Service Event Report

89

Index

91

C1.99 PLUS and ELITE Ultrasound System Service Manual

CHAPTER

1

Introduction Before servicing the SonoSite ultrasound system, please read the information in this manual. This text applies to SonoSite ultrasound system products manufactured after April 1, 2002. Please find service information about products manufactured before April 1, 2002 in C1.51 Ultrasound System Service Manual (P00715), C1.75 Ultrasound System Service Manual (P01118), and C1.9 PLUS Ultrasound System Service Manual (P02287).

1.1

About the System The SonoSite system has various configurations and features. All are described in this manual but not every option may apply to your system. System features are dependent on your system configuration, transducer and exam type. The SonoSite system is a portable, software-controlled, ultrasound system. It has an all-digital architecture. It is used to acquire and display high-resolution, real-time, 2D, color power Doppler (CPD), directional color power Doppler (DCPD), Tissue Harmonic Imaging (THI), including Extended Resolution Harmonics (ERH), M-mode, pulsed wave (PW) Doppler, and continuous wave (CW) Doppler ultrasound images. The system has electrocardiography (ECG), cine review, image zoom, labeling, biopsy, measurements and calculations, serial connection for image transfer, image storage and review, printing and recording with the capability of archiving Doppler with audio output to a videotape. The system setup also has a selection to support optical character recognition (OCR) of the English character set for time, date, patient name, and patient identification. The OCR screen characters are optimized for use with the ALI NewPORT DICOM image capture station peripheral available from ALI. For more information about the ALI NewPORT 2.1, refer to the ALI NewPORT 2.1 Image Capture Station User’s Guide.

Chapter 1: Introduction

1

Currently, the system supports the following broadband transducers: • C60/5-2 MHz 60-mm curved array • C15/4-2 MHz 15-mm micro-curved array • C11/7-4 MHz 11-mm micro-curved array • ICT/7-4 MHz 11-mm intracavitary • L38/10-5 MHz 38-mm linear array System accessories include a SiteStand® mobile docking station, 15 inch display, VCR bracket for SiteStand, SiteCharge® dual battery charger, a power adapter, a battery, ECG cable, video and printer cables, audio cable, SiteLink image manager software, Basic Stand, CRT Stand, ScanPack quick access carrier, Grab and Go Carrying Case, and SitePack® protective carry pack. System peripherals include medical grade (conforming to the requirements of EN60601-1) and non-medical (commercial) grade products. System medical grade peripherals include an external color monitor, video printers, and VCR. System nonmedical grade peripherals include a digital video recorder, a battery charger, a lithium-ion battery, printer, and a handheld monitor. Use of peripherals is covered in the manufacturers’ instructions, which accompany each peripheral. System setup instructions for the use of peripherals are covered in Chapter 3 in the SonoSite Ultrasound System User Guide.

1.2

Audience The intended audience of this manual is properly trained field and in-house service personnel.

1.3

Conventions Used in This Manual These conventions are used in this user guide: • • • • • • •

•

2

Warnings and cautions are identified with the arrow symbol. Control names and references to display elements are presented in bold-face type. Operating instructions are introduced with a statement in bold-face type that ends with a colon. For example: To read this user guide: When the steps in the operating instructions must be performed in a specific order, the steps are numbered. Bulleted lists present information in list format, but they do not imply a sequence. Screen display text is shown in Arial 10 pt. For example: Successful upgrade. The left side of the system is to your left as you face the system. The system handle is at the top of the system, the battery compartment is at the bottom of the system. Note: A note cites information that is a general rule for a procedure, gives an exception to a rule, or provides noncritical information of general interest.

C1.99 PLUS and ELITE Ultrasound System Service Manual

1.4

About the System Software Your SonoSite system contains software that controls its operation. From time to time, SonoSite may provide new software for use with your system. This software is provided using a software update module or a transducer. This software may be either required or optional. A single module or transducer can be used to update one or more systems. When the new software is required, you must install it if you wish to use the new software features (e.g., new transducer). If you choose not to install it, you must remove the transducer and replace it with one that is compatible with the software that is currently installed in your system. When the software is optional, you can either install it or choose to use your existing software. If you choose not to install the software, the system will prompt you again whenever the system is started, and whenever the transducer is disconnected and then reconnected to the system. For more information on software upgrades, refer to Section 4.5, Upgrading the System Software, on page 25.

1.5

Software Licensing Use of the software that you receive from SonoSite is controlled by a license key. A license key is a number sequence containing exactly 12 decimal digits. License keys are obtained from SonoSite or from its authorized representatives. You must obtain one key for each system that will use the new software. See Section 4.6, Obtaining A License Key, on page 27 for information on obtaining a license key. Software that you receive from SonoSite may be installed and will operate for a short period of time without requiring a valid license key. We refer to this period of time as the “grace period.” The grace period is variable. When you first install your software, your SonoSite system will prompt you for a license key. If you have not yet obtained a valid license key, you can elect to use the software as long as the grace period time has not been fully consumed. We refer to this mode of operation as “running in the grace period.” When a system is running in the grace period, all system functions are available. As you use the system, the grace period is slowly consumed. When the grace period has expired, the system will not be usable until a valid license key has been entered. Grace period time is not consumed while the system is powered off or when it is in “sleep” mode. Whenever a system is running in the grace period, the grace period time remaining is available on the license update screen. Refer to Section 4.6.1.1, Displaying the System Information Screen, on page 29. CAUTION: ` When the grace period expires, all system functions except for licensing will be unavailable until you enter a valid license key into the system.

Chapter 1: Introduction

3

4

C1.99 PLUS and ELITE Ultrasound System Service Manual

CHAPTER

2

Safety Please read this information before using the SonoSite ultrasound system. It applies to the ultrasound system, transducers, accessories, and peripherals. A WARNING describes precautions necessary to prevent injury or loss of life. A CAUTION describes precautions necessary to protect the products.

2.1

Electrical Safety This system meets EN60601-1, Class I/internally-powered equipment requirements and Type BF isolated patient-applied parts safety requirements. The ECG cable meets safety requirements of EN 60601-2-25 for Type CF patient-applied part. This system complies with the applicable medical equipment requirements published in the Canadian Standards Association (CSA), European Norm Harmonized Standard, and Underwriters Laboratories (UL) safety standards. See Section 3.5, System Specifications, on page 17. For maximum safety observe the following warnings and cautions: WARNINGS: ` To avoid discomfort or minor risk of patient injury, keep hot surfaces away from the patient. ` Under certain circumstances, the transducer connector and back of the display enclosure can reach temperatures that exceed EN60601-1 limits for patient contact, therefore only the operator shall handle the system. This does not include the transducer face. ` To avoid discomfort or minor risk of operator injury when handling the transducer connector, the system should not be operated for more than 60 minutes continuously in a live-scan mode (as opposed to freeze or sleep modes).

Chapter 2: Safety

5

` ` `

` ` ` ` `

`

` ` ` `

6

To avoid the risk of electrical shock or injury, do not open the system enclosures. All internal adjustments and replacements, except battery replacement, must be made by a qualified technician. To avoid the risk of injury, do not operate the system in the presence of flammable gasses or anesthetics. Explosion can result. To avoid the risk of electrical shock, use only properly grounded equipment. Shock hazards exist if the AC power adapter is not properly grounded. Grounding reliability can only be achieved when equipment is connected to a receptacle marked “Hospital Only” or “Hospital Grade” or the equivalent. The grounding wire must not be removed or defeated. To avoid the risk of electrical shock, before using the transducer, inspect the transducer face, housing, and cable. Do not use the transducer, if the transducer or cable is damaged. To avoid the risk of electrical shock, always disconnect the AC power adapter from the system before cleaning the system. To avoid the risk of electrical shock, do not use any transducer that has been immersed beyond the specified cleaning or disinfection level. Refer to the SonoSite Ultrasound System User Guide for cleaning and disinfection levels. To avoid the risk of electrical shock and fire hazard, inspect the AC power adapter cord and plug on a regular basis. Ensure they are not damaged. To avoid the risk of electrical shock, use only accessories and peripherals recommended by SonoSite. Connection of accessories and peripherals not recommended by SonoSite could result in electrical shock. Contact SonoSite or your local representative for a list of accessories and peripherals available from or recommend by SonoSite. To avoid the risk of electrical shock, use commercial grade peripherals recommended by SonoSite on battery power only. Do not connect these products to AC mains power when using the system to scan or diagnose a patient/subject. Contact SonoSite or your local representative for a list of the commercial grade peripherals available from or recommended by SonoSite. To prevent injury, only use market cleared ECG electrodes and cables. To avoid the risk of electrical shock to the patient/subject, ensure proper assembly of the ECG electrodes and cables. To avoid the risk of electrical shock to the patient/subject, do not touch the system battery contacts while simultaneously touching a patient/subject. To prevent injury to the operator/bystander, the transducer must be removed from patient contact before the application of a high-voltage defibrillation pulse.

C1.99 PLUS and ELITE Ultrasound System Service Manual

CAUTIONS: ` Although your system has been manufactured in compliance with existing EMC/ EMI requirements (EN60601-1-2), use of the system in the presence of an electromagnetic field can cause degradation of the ultrasound image. If this occurs often, SonoSite suggests a review of the system environment. Identify and remove the possible sources of the emissions or move your system. ` Electrostatic discharge (ESD), or static shock, is a naturally occurring phenomenon. ESD is common in conditions of low humidity, which can be caused by heating or air conditioning. Static shock is a discharge of the electrical energy from a charged body to a lesser or non-charged body. The degree of discharge can be significant enough to cause damage to a transducer or an ultrasound system. The following precautions can help reduce ESD: anti-static spray on carpets, anti-static spray on linoleum, and anti-static mats. ` Do not use the system if an error message appears on the image display: note the error code; call SonoSite or your local representative; turn off the system by pressing and holding the power switch until the system powers down. ` To avoid increasing the system and transducer connector temperature, do not block the airflow to the ventilation holes on the back of the system.

2.1.1

Equipment Protection To protect your ultrasound system, transducer, and accessories, follow these precautions. CAUTIONS: ` The ECG cable emits electromagnetic interference when connected to the SonoSite system. It is not approved for use in-flight on aircraft. ` Excessive bending or twisting of cables can cause a failure or intermittent operation. ` Improper cleaning or disinfecting of any part of the system can cause permanent damage. For cleaning and disinfecting instructions, refer to the SonoSite Ultrasound System User Guide. ` Do not submerge the transducer connector in solution. The cable is not liquidtight beyond the transducer connector/cable interface. ` Do not use solvents such as thinner or benzene, or abrasive cleaners on any part of the system. ` Remove the battery from the system if the system is not likely to be used for some time. ` Do not spill liquid on the system. ` The top membrane of the phantom is delicate and can be damaged if handled improperly. Use minimum force when coupling the transducer to the phantom. ` Do not handle PCBs without proper static protection. Improper handling may damage components. ` Incorrect assembly or configuration or using an improper power source may damage the system. ` Do not touch the scanhead connector pins.

Chapter 2: Safety

7

2.2

Battery Safety To avoid the risk of injury, follow the warnings and cautions to make sure that the battery does not burst, ignite, or generate heat or fumes. WARNINGS: ` The battery has a safety device. Do not disassemble or alter the battery. ` Charge the batteries only when the ambient temperature is between 0° and 40°C (32° and 104°F). ` Do not short-circuit the battery by directly connecting the positive and negative terminals with metal objects. ` Do not heat the battery or discard it in a fire. ` Do not expose the battery to temperatures over 60°C (140°F). Keep it away from fire and other heat sources. ` Do not charge the battery near a heat source, such as a fire or heater. ` Do not leave the battery in direct sunlight. ` Recharge the battery only with the SiteCharge dual battery charger or the system. ` Do not pierce the battery with a sharp object, hit it, or step on it. ` Do not use a damaged battery. ` Do not solder a battery. ` When connecting the battery to the SiteCharge dual battery charger or to the system, never reverse the polarity of the battery terminals. ` The polarity of the battery terminals are fixed and cannot be switched or reversed. Do not force the battery into the system or the SiteCharge dual battery charger. ` Do not connect the battery to an electrical power outlet. ` Do not continue recharging the battery if it does not recharge after two successive six hour charging cycles. CAUTIONS: ` To avoid the battery bursting, igniting, or fumes from the battery and causing equipment damage, observe the following precautions: ` Do not immerse the battery in water or allow it to get wet. ` Do not put the battery into a microwave oven or pressurized container. ` If the battery leaks or emits an odor, remove it from all possible flammable sources. ` If the battery emits an odor or heat, is deformed or discolored, or in any way appears abnormal during use, recharging or storage, immediately remove it and stop using it. If you have any questions about the battery, consult SonoSite or your local representative. ` Store the battery between -20°C (-4°F) and 60°C (140°F). ` Use only SonoSite batteries.

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C1.99 PLUS and ELITE Ultrasound System Service Manual

2.3

Biological Safety Observe the following precautions related to biological safety. WARNINGS: ` To prevent misdiagnosis, do not use the ECG trace to diagnosis cardiac rhythms. The SonoSite ECG option is a non-diagnostic feature. ` To prevent injury, only use market cleared ECG electrodes and cables. ` Non-medical (commercial) grade peripheral monitors have not been verified or validated by SonoSite as being suitable for diagnosis. ` Do not use the system if it exhibits erratic or inconsistent behavior. Discontinuities in the scanning sequence are indicative of a hardware failure that must be corrected before use. ` Do not use the system if it exhibits artifacts on the LCD screen, either within the clinical image or in the area outside of the clinical image. Artifacts are indicative of hardware and/or software errors that must be corrected before use. ` Some transducer covers contain natural rubber latex and talc, which can cause allergic reactions in some individuals. Refer to the FDA Medical Alert, March 29, 1991. ` Perform ultrasound procedures prudently. Use the ALARA (as low as reasonably achievable) principle. ` SonoSite does not currently recommend a specific brand of acoustic standoff.

2.4

Labeling Symbols Labeling symbols for SonoSite products can be found in the user guide for each product.

Chapter 2: Safety

9

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C1.99 PLUS and ELITE Ultrasound System Service Manual

3

System Overview

3.1

Theory of Operation

CHAPTER

The SonoSite ultrasound system has seven major functional groups: the transducer, the acquisition subsystem, the processing subsystem, the display subsystem, the control subsystem, the user interface subsystem, and the power subsystem. Figure 3.1 shows how these functions interact. AQ bus

RF bus

External video to monitor, VCR, printer ports

Transducer

Display subsystem

Video bus User interface subsystem

Control bus

Acquisition subsystem

Control subsystem

To all subsystems

Serial bus

Display power

Power subsystem

Logic power

Battery pack

Pulser voltage

Power adapter

External power

Figure 3.1

System Block Diagram

Chapter 3: System Overview 11

3.1.1

Transducer The transducer elements convert the pulser voltage to acoustic energy during the “transmit” portion of the ultrasound acquisition cycle. Also, the transducer elements convert the acoustic echo to voltage in the “receive” portion of the acquisition cycle. The system transducers have more than 64 elements. The acquisition subsystem senses the voltage developed on the transducer elements.

3.1.2

Acquisition Subsystem The acquisition subsystem consists of a beamformer and an interface to the transducer. The beamformer times the “transmit” pulses to focus the acoustic beam. Also, the beamformer amplifies the low-level echo signal and times and focuses the “receive” information.

3.1.3

Processing Subsystem The high-speed processing subsystem interfaces with the beamformer. The processing subsystem demodulates, filters, detects, and compresses the signal supplied by the beamformer. Next, it sends this data to the display subsystem.

3.1.4

Display Subsystem The display subsystem converts the detected ultrasound data into picture elements (pixels). The software user interface graphics are combined with the ultrasound information and converted to a video stream. The external video ports support NTSC and PAL format.

3.1.5

Control Subsystem The control subsystem consists of the central processing unit, program and video memory, permanent image storage and retrieval memory, and a connection to the user interface keys. The control software includes the acoustic power and intensity software power group monitors, and a beamformer monitor. This software makes the system operate within acoustic power and intensity limits, which guarantees a level of patient safety.

12

C1.99 PLUS and ELITE Ultrasound System Service Manual

3.1.6

User Interface Subsystem The user interface subsystem comprises the software user interface and the form factor. The software user interface is the interaction between the user and the screen layout components. The form factor is the device’s physical attributes: buttons, location and grouping of buttons and the device size, shape, and weight. Dedicated controls, or often-used features, are grouped according to user workflow.

3.1.7

Power Subsystem The power subsystem provides power and protects the hardware from destructive or unsafe conditions. This subsystem’s hardware and software monitors detect failures in the device. Upon detecting a fault, the system disables the pulser supply, and signals an error to the control subsystem. The power subsystem includes the battery pack and the battery charging electronics.

3.2

Components The SonoSite system components are identified in Section 1.2, Audience, on page 2.

Chapter 3: System Overview 13